BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 2, 9MM

    MDR report key: 16649378 · Received March 30, 2023

    Report

    Report Number
    1038671-2023-00551
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 6, 2023
    Report Date
    February 18, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174284
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION CONCOMITANT DEVICE(S): 5266006 02-010-03-0220 - LOGIC CR FEMORAL CEM, LEFT SZ 2, 5269825 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T, 5170399 200-02-29 - THREE PEG PATELLA 29MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 MONTHS POST OP THE INITIAL LEFT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE THE RECALL. SURGEON DID NOT PROVIDE ANY MORE DETAILS ON REASON FOR THE REVISION TO THE REPRESENTATIVE. NO BREAKAGE OF DEVICE OR SURGICAL DELAY PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION MEDICAL HISTORY PROVIDED. UNABLE TO OBTAIN X-RAYS/PHOTOS. PRODUCT NOT RETURNING HOSPITAL WOULD NOT ALLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443776 LOGIC CR TIB INSERT SLOPE+, SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862174284

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female